510(k) Report

Devices descending from K173780

10 later devices reach EchoMD Automated Ejection Fraction Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220956Libby Echo:PrioDyad Medical, Inc.20221—
+1K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+1K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+2K252105Ligence HeartLigence Uab20250—
+2K250670EchoConfidence (USA)Mycardium AI Limited20250—
+2K241430EchoMeasureIcardio.Ai20240—
+2K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+2K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+3K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+3K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—